Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy

Samsung Medical Center

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Drug: Midazolam; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05836545

2022-08-2391

Details and patient eligibility

About

The goal of this clinical trial is to compare the efficacy of remimazolam with midazolam in patients undergoing gastrointestinal endoscopy. The main questions it aims to answer are:

• Superiority of total procedure time in remimazolam compared to midazolam
• The success of sedation time

This is the single blind study.; Patients will not know what they are given as the sedation drug If there is a comparison group: Researchers will compare patients with midazolam group to see if remimazolam group is superior to midazolam group

Enrollment: 132 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who agreed for this clinical trials
• Patients who want diagnostic endoscopy under sedation
• The total procedure time which is predicted within 15 minutes
• ASA >=2
• BMI more than 18.5kg/m2, less than 30kg/m2

Exclusion criteria

• Patients who have stomach illness
• Patients with respiratory disease
• Mallampati Score>=3
• Systolic BP >160mmHg or <90mmHg
• Refractory Hypertension
• Uncontrolled glaucoma
• Severe liver failure or chronic kidney disease
• Patients with drug abuse or alcohol abuse within 1 year
• Patients who are sensitive for certain medication (such as benzodiazepine, remimazolam)
• Obstructive sleep dyspnea patients
• Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Pregnant, breast feeding patient

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

Midazolam

Active Comparator group

Description:

The patient with midazolam

Treatment:

Drug: Midazolam

Remimazolam

Experimental group

Description:

The patient with remimazolam

Treatment:

Drug: Remimazolam